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NCT Number: NCT05671991

Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease

The main purpose of the study is to determine if empagliflozin can reduce peritoneal glucose absorption in patients with end stage renal diease (ESRD) on peritoneal dialysis.

This is a randomized, placebo controlled, acute crossover study of empagliflozin in an anticipated 30 chronic PD patients, with an 8 week "pre post" open label extension in all 30 patients where they will receive empagliflozin daily.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yale University

New Haven, Connecticut, 06510, United States

Location status: Recruiting

Location contact

Veena Rao, PhD

CONTACT

About this study

Participants will undergo three study visits, and up to 4 safety visits, over 9 weeks.

At 7 AM in the first study visit, the participants will have taken 25mg empagliflozin once or matching placebo, thus producing peak plasma levels by 10 AM. One week later the participant will return for the crossed over to the alternate study drug.

At the conclusion of the 2nd study visit, all participants will be provided with empagliflozin 10mg tabs to be taken daily for 56 days (8 weeks). At each study visit and safety visit, participants will undergo a PET test.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients actively undergoing PD with a reliably functioning PD catheter
  • Stable peritoneal dialysis prescription
  • PD vintage > 3 months
  • Age >18 years of age

Exclusion criteria

  • History of type 1 diabetes, diabetic ketoacidosis, "brittle" diabetes or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 6 months
  • Use of an SGLT2 inhibitor within the prior 30 days
  • 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
  • Anemia with hemoglobin <8g/dL
  • Inability to give written informed consent or follow study protocol
  • Contraindication to receiving loop diuretics

Treatment and study plan

Empagliflozin 25 mg vs Placebo

Drug

Acute Study- Empagliflozin 25 mg vs Placebo on D1 then alternate therapy on D7

Empagliflozin 10 MG

Drug

Chronic Study- Empagliflozin 10 mg for 8 weeks

Primary outcomes

  1. Glucose absorption with empagliflozin vs. placebo

    Time frame: Day 0 to Day 63

    Total glucose absorption in grams with empagliflozin vs. placebo

Secondary outcomes

  1. Ultrafiltration volume with empagliflozin vs. placebo- acute study

    Time frame: at 4 hours

    Ultrafiltration volume (in liters) at 4 hours with empagliflozin vs. placebo.

  2. Change in plasma glucose levels with empagliflozin vs. placebo- acute study

    Time frame: Day 0 to Day 63

    Change in plasma glucose levels during PD dwell with empagliflozin vs. placebo- acute study

  3. Increase in natriuresis with empagliflozin vs. placebo-acute study

    Time frame: Day 0 to Day 63

    Natriuresis determined by FENa

  4. Change in peritoneal fluid inflammatory markers

    Time frame: Day 0 to Day 63

    Change in levels of IL-6 and CA-125 (in pg)

  5. Change in PET test parameters

    Time frame: Day 0 to Day 63

    Change in peritoneal equilibration test parameters, measurement of solute transport across the peritoneal membrane (standard test carried out in PD patients to assess solute trasnport across membrane)

  6. Change in total body water and extracellular water

    Time frame: Day 0 to Day 63

    Change in total body water and extracellular water, using heaving water (D20)

Study contacts

Contact information is provided by the study sponsor or research team.

Kara Otis

CONTACT

[email protected]

203-737-3571

Veena Rao, PHD

CONTACT

[email protected]

203-737-3571

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Acronym: EMPA-PD

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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